MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-09-11 for GENTIAN MARKING PAD * 581057 manufactured by Bd Ophthalmic Systems.
[317707]
The account thinks the marking pads cuased dlk in 7 cases in 8/2003.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2003-00003 |
| MDR Report Key | 494627 |
| Report Source | 05 |
| Date Received | 2003-09-11 |
| Date Mfgr Received | 2003-08-13 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2003-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAT FILOSA |
| Manufacturer Street | 411 WAVERLEY OAKS ROAD BLDG. 2, SUITE 229 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTIAN MARKING PAD |
| Generic Name | BD VISIMARK VIOLET MARKING PAD |
| Product Code | HMQ |
| Date Received | 2003-09-11 |
| Returned To Mfg | 2003-08-21 |
| Model Number | * |
| Catalog Number | 581057 |
| Lot Number | 3155268 |
| ID Number | * |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 483339 |
| Manufacturer | BD OPHTHALMIC SYSTEMS |
| Manufacturer Address | 411 WAVERLEY OAKS ROAD BLDG. 2, SUITE 229 WALTHAM MA 02452 US |
| Baseline Brand Name | BD VISIMARK GENTIAN VIOLET MARKING PAD |
| Baseline Generic Name | MD VISIMARK GENTIAN MARKING PAD |
| Baseline Model No | NA |
| Baseline Catalog No | 581057 |
| Baseline ID | NA |
| Baseline Device Family | BD VISITEC PRE-INKED MARKING PADS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K884718 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-11 |